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Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting

American Journal of Obstetrics and Gynecology, In Press, Uncorrected Proof, Available online 16 June 2016, Available online 16 June 2016

Background

Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported.

Objectives

We aimed to describe concordance between physicians’ financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year.

Study Design

Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content.

Results

Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract.

Conclusion

Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings.

Key words: financial disclosures, Open Payments database, Sunshine Act.

Physicians and hospital systems often have relationships with biomedical manufacturers. These relationships are established to promote and develop innovative ideas and products and support physician education. Companies often provide funding for these efforts.

Industry’s share of total investment in biomedical research and development increased substantially from 32% in 1980 to 62% in 2000.1 In 2001, US pharmaceutical companies spent more than $21 billion promoting prescription drugs, and 84% of the marketing was directed toward physicians.2 In 2007, 94% of US physicians surveyed nationally reported that they had a relationship with industry.3

Industry’s financial influence leaves a significant impact on physicians’ practice and research results. Physicians who have accepted money from pharmaceutical companies are more likely to request additions to the hospital formulary including drugs manufactured by those same companies.4

Prescribing practices are also influenced by interactions between physicians and pharmaceutical companies. Physicians who receive financial support from industry are more likely to prescribe those industries’ medications.5, 6, 7, and 8 Industry-sponsored studies are more likely to reach conclusions that were favorable to the sponsor than nonindustry studies.1 and 9

Despite evidence that industry relationships influence physician decision making, the majority of physicians deny that their own industry relationships influence their practice.10, 11, 12, and 13 Although physician-industry relationships are valuable, transparency is key to maintaining a professionalism. Disclosing financial relationships or other invested interest in companies reveals potential biases in physician behavior. Currently physician scientists are asked to divulge industry alliances when presenting scientific work, including presentations at scientific meetings and on publications to ensure transparency and reveal potential biases. Until recently, all disclosures were at the discretion of the physician.

The Physician Payments Sunshine Act was created from the Patient Protection and Affordable Care Act passed in 2010. This national disclosure program requires public reporting of payments to physicians and teaching hospitals from applicable manufacturers and group purchasing organizations.

The Centers for Medicare and Medicaid Services was assigned to collect information from these companies in a publicly available database called the Open Payments Program (http://www.cms.gov/openpayments). The purpose of this system is to improve transparency to consumers of possible biases in physician practice and research.

Applicable manufacturers or group purchasing organizations are included in the Centers for Medicare and Medicaid Services database if they are located and/or conduct activities within the United States and produce, purchase, arrange, and/or negotiate the purchase of pharmaceuticals, devices, biological agents, or medical supplies. At least 1 product must be reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program, and either the product must require the physician’s authorization/prescription to administer or the product requires premarket approval/notification by the Food and Drug Administration.14

All transactions including single payments greater than $10 and multiple payments exceeding $100 qualify for reporting. The Centers for Medicare and Medicaid Services lists all transactions with applicable companies including company names, number of transactions, physician payment amounts, and types of payments. Data collection began Aug. 1, 2013, and 2014 was the first year this information became publicly available.

One way to measure physician transparency is to compare industry relationships reported in the Open Payment Program with physician self-disclosure. We aimed to evaluate the concordance of authors’ self-reported disclosures at the 41st annual scientific meeting of the Society of Gynecologic Surgeons in 2015 compared with those published in the Centers for Medicare and Medicaid Services Open Payments Program in the same year. We hypothesized that financial relationships between authors and medical industry are underreported at a scientific meeting, and many physician undisclosed associations with companies were directly related to the subject of the research being presented.

Materials and Methods

We performed a retrospective cohort study to compare the financial disclosures between those physicians responsible for the scientific content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons in 2015 and disclosures published on the online Centers for Medicare and Medicaid Services database.

This was an institutional review board–exempt study because all data were publicly available. The Journal of Minimally Invasive Gynecology, published in March/April 2015, listed the scientific program committee members as well as all abstracts presented at the annual meeting. Abstracts included oral presentations, oral poster presentations, nonoral poster presentations, video presentations, video fest, and the video café. The Society of Gynecologic Surgeons instructs all authors to disclose conflicts “whether or not this relationship is directly related to the material being presented,” and physician self-disclosures were published with their abstracts.

The authors and Society of Gynecologic Surgeons scientific committee members responsible for the content at the meeting were identified from the abstract book. Demographic information including sex, specialty, level of training, type of institution (ie, private practice, teaching hospital) was collected by searching publicly available Internet sites using the authors’ name and institution. All presenters except for those who were identified as nonphysicians and physicians practicing medicine outside the United States were included in this study. Physicians meeting eligibility criteria were searched in the Centers for Medicare and Medicaid Services Open Payments database.

Centers for Medicare and Medicaid Services payment information was compared with self-reported financial disclosures to determine the disclosure rate. If an author was listed on more than one abstract, disclosures were summed across abstracts and compared in total with the companies listed on the Centers for Medicare and Medicaid Services.

Abstracts do not include a monetary value with the self-disclosed companies. To determine the monetary value of nondisclosed affiliations, the total amount of money from companies listed on the Centers for Medicare and Medicaid Services and self-disclosed by the authors in the abstracts was subtracted from the total amount reported in the Centers for Medicare and Medicaid Services.

Others have proposed a cutoff value for associations because associations of very low value may have been disclosed by a company without the author’s awareness, and small amounts may not have as strong an influence as larger amounts on physician behavior. We performed a subanalysis by excluding all Centers for Medicare and Medicaid Services total value listings less than $100.

Relatedness of nondisclosed conflicts was also evaluated. Two authors each independently reviewed each nondisclosed Centers for Medicare and Medicaid Services listing to determine whether the company’s product line was related to the content of the abstract. The companies were categorized by their products or services into pharmaceutical, surgical, or medical relevant to the treatment of pelvic floor dysfunction. Abstracts were similarly categorized.

A disclosure was determined related to the content of the abstract if the company produced a product in the same category as the abstract. For example, a company involved with producing medications for overactive bladder was determined relevant to a study evaluating the outcomes of overactive bladder treatments. Both reviewers agreed on the relatedness assignment. If reviewers did not agree, discrepancies were adjudicated with a third party.

Study data were entered into REDCap.15 Descriptive statistics were used to describe author characteristics, associations, and disclosure rates.

Results

The authors and Society of Gynecologic Surgeons scientific committee members from the 41st scientific meeting totaled 449 people. After excluding nonphysicians and those working outside the United States, 335 were included for review. Scientific committee members did not have separate disclosures included in the Journal of Minimally Invasive Gynecology abstract book unless they were authors listed in the abstract book. Those Society of Gynecologic Surgeons scientific committee members without abstracts were still included because of their responsibility for the scientific content of the meeting. Most presenters were female, attending physicians working at teaching hospitals and specialized in Female Pelvic Medicine and Reconstructive Surgery (Table 1).

Table 1 Physician characteristics

Demographic characteristics n Percentage
Gender
 Female 191 57
 Male 144 43
Medical specialty
 FPMRS 173 51.6
 Obstetrics-gynecology 114 34.0
 Gynecologic oncology 11 3.3
 MIS 8 2.4
 Urology 6 1.8
 REI 5 1.5
 General surgery 4 1.2
 Colorectal surgery 3 0.9
 Internal medicine 3 0.9
 Plastic surgery 2 0.6
 Cardiology 2 0.6
 Radiology 2 0.6
 Neurosurgery 1 0.3
 Anesthesiology 1 0.3
Type of institution of physician practice
 Teaching hospital 318 94.9
 Private practice 8 2.4
 Military 7 2.1
 Other 2 0.6
Level of training
 Attending physician 233 69.6
 Resident 55 16.4
 Fellow 47 14.0

FPMRS, female pelvic medicine and reconstructive surgery; MIS, minimally invasive surgery; REI, reproductive endocrinology and infertility.

Thompson et al. Disclosing financial affiliations with industry. Am J Obstet Gynecol 2016.

Of the 335 physicians, 209 of the 335 (62%) had disclosures listed in the Centers for Medicare and Medicaid Services database, but only 24 of 335 authors (7.2%) listed at least 1 company in the financial disclosure section of their abstract. Of the 24 authors with self-disclosures, only 5 of 24 physicians (20.8%) accurately included all of the companies listed on Centers for Medicare and Medicaid Services. The remaining 311 of 335 physicians (92.8%) stated in their abstract that there was nothing to disclose.

Overall, 129 people (38.5%) reported accurate financial disclosures, meaning that they disclosed nothing with their abstract that was confirmed with a review of the Centers for Medicare and Medicaid Services listings, or they disclosed everything listed in the Centers for Medicare and Medicaid Services. Reporting disclosures were consistent for the 85 authors with more than 1 abstract; 4 presenters varied in their disclosures between abstracts.

The total monetary value of the 2014 Centers for Medicare and Medicaid Services disclosures associated with the authors and scientific committee members was nearly 2 million dollars (Table 2). These transactions were categorized within the Centers for Medicare and Medicaid Services database into general payments (56.6%), research (3.6%), associated research (39.7%), and investments (0.1%). General payments included honoraria, education, travel/lodging, food/beverage, gifts, grants, entertainment, royalties/license, consulting fees, and compensation for other services (Table 2).

Table 2 CMS Categories of transactions

Type of transaction Total amount Number of transactions Minimum Maximum Median
General payments $1,130,683.19 3283 $0.26 $31,000.00 $23.61
Education $313,709.80 129 $1.26 $31,000.00 $99.00
Consulting $195,833.60 84 $1.26 $8312.50 $2000.00
Compensationa $193,839.13 81 $10.33 $6800.00 $2400.00
Travel/lodging $170,626.68 486 $1.14 $10,890.26 $133.53
Honoraria $122,180.00 28 $80.00 $8000.00 $4000.00
Food/beverage $99,606.88 2463 $0.26 $6798.56 $18.44
Royalties/license $32,405.79 5 $698.53 $25,000.00 $1093.20
Gift $1815.01 3 $12.08 $1483.00 $319.93
Grant $622.22 2 $22.22 $600.00 $311.11
Entertainment $44.06 2 $15.21 $28.85 $22.03
Research $71,946.34 36 $24.69 $10,000.00 $1750.00
Associated Research $792,549.44 67 $150.00 $105,360.00 $200.00
Investments $2000.00 1
Total $1,997,178.97 3387

aCompensation for services other than consulting, including serving as faculty or as a speaker at a venue other than continuing education program.

CMS, Centers for Medicare and Medicaid Services.

Thompson et al. Disclosing financial affiliations with industry. Am J Obstet Gynecol 2016.

Whereas the majority of transactions (2463 of 3283, 75%) were labeled as food/beverage, the most money in general payments was spent on education and consulting fees. The number of transactions listed for a physician ranged from 1 to 366 (median, 6 transactions). The value of these transactions per physician ranged from $11.72 to $405,903.36 (interquartile ranges, $106.95; $321.01; $2069.14; $403,394.54). Nearly half of those with Centers for Medicare and Medicaid Services accounts (47.8%) had recorded values greater than $500.00.

The value of disclosures from the abstracts that were also listed on the Centers for Medicare and Medicaid Services database was $674,007.25. The total value of the Centers for Medicare and Medicaid Services reports that were not disclosed on abstracts was $1,323,171.72, accounting for 66.3% of all Centers for Medicare and Medicaid Services payments to authors and committee members at the meeting.

Before any transactions are made public, the Centers for Medicare and Medicaid Services posts a 45 day review period, which allows physicians to dispute any of the transactions. None of the transactions were disputed in the Centers for Medicare and Medicaid Services by any of the physicians.

A subanalysis that excluded accounts with total Centers for Medicare and Medicaid Services values of less than $100 was performed, which left 168 accounts with total values ≥$100. The overall total value of the 41 accounts with values less than $100 was 2007.06. The accurate disclosure rate excluding those accounts less than $100 is then 177 of 335 (52.8%).

One hundred twenty-two different companies were identified from the Centers for Medicare and Medicaid Services accounts and were affiliated with the authors and committee members. Ten of these companies were responsible for 63% of the total payments, or $1,266,402 (Table 3). Payments included all categories of transactions (general payments, research, associated research, and investments).

Table 3 CMS companies

Company Percentage of accounts listing the company Number of transactions Total amount paid Minimum payment Maximum payment Median payment
Medtronic 34.9 347 $64,704.23 $0.86 $6800.00 $31.25
AMS 30.1 311 $91,774.00 $1.14 $7658.00 $50.00
Astellas 30.1 316 $96,028.22 $0.26 $27,461.00 $18.44
Allergan 23.9 232 $85,470.85 $1.48 $21,025.60 $23.96
Boston Scientific 22.9 132 $24,2870.30 $5.05 $65,000.00 $96.35
Pfizer 22.5 182 $81,231.67 $0.38 $18,718.50 $11.97
Coloplast 20.6 345 $395,773.40 $0.85 $31,000.00 $73.06
Ethicon 17.7 89 $25,774.37 $0.77 $8312.50 $30.59
Intuitive 15.8 296 $180,791.20 $0.98 $8000.00 $40.23
Actavis 15.3 150 $1983.26 $0.98 $99.99 $13.12
Total 2268 $1,266,402.00

CMS, Centers for Medicare and Medicaid Services.

Thompson et al. Disclosing financial affiliations with industry. Am J Obstet Gynecol 2016.

Although Medtronic, American Medical Systems, and Astellas Pharma Inc were the companies most commonly listed with the authors’ Centers for Medicare and Medicaid Services accounts, Boston Scientific, Coloplast, and Intuitive Surgical reported the most money.

Relatedness between the Centers for Medicare and Medicaid Services companies and abstract subject was determined concordant in all cases by the 2 reviewers. Of the 209 physicians with Centers for Medicare and Medicaid Services transactions, the majority (68%) had at least 1 company listed in the Centers for Medicare and Medicaid Services that was determined to be related to the subject of their abstract. After excluding the self-disclosures listed with the abstracts, 139 of 209 physicians (66.5%) still had at least 1 Centers for Medicare and Medicaid Services company related to the abstract that was not disclosed. The range of companies related per physician was from 1 to 13 (median, 2 companies).

Comment

We found that the accuracy of self-reported financial disclosures at the annual meeting of the Society of Gynecologic Surgeons in 2015 was poor. Despite instructions to disclose all financial relationships, the majority of authors and committee members with company affiliations did not include all transactions documented in the Centers for Medicare and Medicaid Services Open Payments database. Furthermore, the majority of nondisclosed companies was deemed relevant to the scientific content of the abstract presented.

We also found that the amount of money from companies associated with physicians presenting their scientific work varied greatly as did the number of affiliations with companies. Finally, we found that financial associations with physicians were concentrated in a few companies that produce gynecological products.

Research in conflicts of interest is limited since the creation of the Centers for Medicare and Medicaid Services Open Payments database. In 2007, payments made by manufacturers of joint prostheses to authors of presentations and committee or board members at the annual meeting of the American Academy of Orthopaedic Surgeons were compared with the disclosure of possible conflicts in the abstract book of the meeting. The authors of this paper found that the overall disclosure rate for possible conflicts was 245 of 344 payments (71.2%), disclosure rates higher than those in our study.

In the orthopedic study, physicians were surveyed for reasons that they did not disclose all industry affiliations. Physicians reported the most common reasons for nondisclosure was that they believed that the payment was unrelated to the presentation topic and that the physician had misunderstood the disclosure requirements.16

Underreporting in our study may be for similar reasons: physicians may have felt that the association with industry was not related to the content of the abstract or they may have misunderstood the directions to authors for abstract presentation. Nonetheless, a significant number of affiliations remained undisclosed.

Disclosures may also vary between the abstract and oral presentation of scientific work. A comparison of disclosures on published abstracts and oral presentations at the annual scientific meeting of the American Urogynecologic Society found that 13% of presentations did not include a disclosure slide, and the discordance in disclosures between the printed abstract and oral presentation was present in nearly half.18 The presentation slides were not available for this study to compare the difference in disclosure practices.

Self-disclosure rates vary widely between physicians. We found a significant number of authors failed to disclose companies that were pertinent to the content of the abstract. The effect of industry affiliations on physician behavior has been previously reported, although many physicians believed that their affiliations would not affect their practice of medicine or scientific interpretation of results.1, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13 This belief that the affiliation was not related or would not influence the author may have similarly influenced the low disclosure rates of physicians in our study.

Physicians’ limited knowledge regarding the Open Payments database may have greatly influenced our study results. None of the physicians in this study disputed any of the transactions reported in 2014, the first year of complete data in the Open Payments database. Although applicable companies are required by law to submit their disclosures to the Centers for Medicare and Medicaid Services, no other safeguards are in place to review these reports except the physicians or hospital systems involved.

To dispute a transaction, a physician must first register with the Centers for Medicare and Medicaid Services’s Enterprise Portal and Open Payments and explain why the transaction is deemed inaccurate. The company is then contacted, and a consensus must be made within 15 days between the physician and company involved.14 Although some company disclosure may have been made in error and were not disputed, these errors are unlikely to explain the high nondisclosure rate we observed.

Strengths of this study include the use of public databases that are mandated to report financial affiliations. In addition, the use of a publicly available record of disclosures as published in the Journal of Minimally Invasive Surgery replicates the information available to attendees of the annual meeting of the Society of Gynecologic Surgeons.

Weaknesses include that not all companies with financial relationships with physicians are included in the Centers for Medicare and Medicaid Services, and affiliations with companies may exist for some authors that remain undisclosed. For example, companies that pay physicians royalties for scientific writings are not disclosed on the Centers for Medicare and Medicaid Services but are often reported as self-disclosures.

In addition, we do not know whether the disclosure slide presented with the abstract at the annual meeting more accurately included all financial affiliations than those printed in the abstract book. We chose to compare disclosures between the March 2015 Society of Gynecologic Surgeons annual meeting with the year in which the Centers for Medicare and Medicaid Services payments were made publicly available in 2014, and the overlap in time frames may have led to discrepancies that are explained because of the timing of the affiliation. However, abstracts were due to the Society of Gynecologic Surgeons in October 2014. Nonetheless, at the time of presentation, it is reasonable to expect that recent disclosures would be made available to attendees.

Perhaps better instructions to authors regarding the time frame of the disclosures would improve concordance between the Centers for Medicare and Medicaid Services and meeting disclosures. Although we chose to examine disclosures of a single society meeting, it is probable that the same discrepancies would be found at other gynecological meetings.

The purpose of the Centers for Medicare and Medicaid Services database is to increase transparency regarding the extent and nature of relationships between physicians, teaching hospitals, and industry manufacturers so patients can make better informed decisions when choosing health care professionals and treatment decisions. In addition, the Centers for Medicare and Medicaid Services was designed to help and deter inappropriate financial relationships between industry and physicians.14

Currently it is unclear whether the Centers for Medicare and Medicaid Services database is reaching those goals. Further studies are required to determine whether there is any appreciable change in self-disclosures after the Centers for Medicare and Medicaid Services Open Payments database has become more widely utilized and publicized. From our study, we determined that physicians must take a greater responsibility for accurate disclosure practices and improve their awareness of the Sunshine Act including the Open Payments database and disputing process.

Uncited Figure and Reference

Figure, 17.

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Figure Study participantsThis figure describes the participants included for further review in the CMS database. The participants are categorized by those with CMS accounts, those with companies listed in their abstract disclosure statement, and those who included all CMS companies in the disclosure statement.CMS, Centers for Medicare and Medicaid Services.Thompson et al. Disclosing financial affiliations with industry. Am J Obstet Gynecol 2016.

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Footnotes

a Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM

b Division of Urogynecology, and Clinical and Translational Science Center, University of New Mexico, Albuquerque, NM

Corresponding author: Rebecca G. Rogers, MD.

The views expressed herein are those of the authors and do not necessarily represent the official views of the National Institutes of Health.

This study was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through grant UL1 TR000041.

Dr Dunivan receives research support from Pelvalon, Inc unrelated to the submitted work. Dr Jeppson received a general payment from American Medical Systems listed on the Centers for Medicare and Medicaid Services unrelated to the submitted work. Dr Komesu reports grants from National Institutes of Health–funded grant PA11-260, nonfinancial support from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health through grant 8UL1TR000041, The University of New Mexico Clinical and Translational Science Center, and grants from the National Institutes of Health: U grant funding the Pelvic Floor Support Disorders Network via the Eunice Kennedy Shriver National Institute of Child Health and Human Development (institute): general payment through uroplasty listed on the Centers for Medicare and Medicaid Services; all of which are unrelated to the submitted work. Dr Cichowski received a general payment from American Medical Systems listed on the Centers for Medicare and Medicaid Services unrelated to the submitted work. Dr Rogers is DSMB chair for the TRANSFORM trial sponsored by American Medical Systems and receives royalties for scientific writings from UptoDate and McGraw-Hill. The other authors report no conflict of interest.

Cite this article as: Thompson JC, Volpe KA, Bridgewater LK, et al. Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting. Am J Obstet Gynecol 2016;xxx:xx-xx.